Senior Health Authority Reporting Analyst

At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.

We provide an inclusive work environment where each person is considered as an individual.

At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:
Quality

Job Sub Function:
Customer/Commercial Quality

Job Category:
Professional

All Job Posting Locations:
Ciudad Juarez, Chihuahua, Mexico

Job Description:

Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness.

Learn more at https://www.jnj.com/medtech

We are searching for the best talent for Senior Health Authority Reporting Analyst to be in Juarez City.

You will be responsible for:


* Demonstrate world-class customer support and maintain knowledge of relevant Operating Company's products and services.


* • Assess, process, and close complaint files within scope of internally and externally manufactured products in accordance with associated complaint handling procedures and CQ expectations.

This may include assigning product experience and patient codes.

Utilize MD Workflow reports to identify tasks and manage common Email inboxes.


* • Make regulatory reporting determinations on applicable files for one or more Business Units.

Execute file reviews, making and/or reassessing MDR and/or MDV decisions and managing relevant complaint file activities.


* • File Medwatch report forms within required timelines as applicable.


* • File MDVs in accordance with EEA, Switzerland and Turkey, candidate countries and other third countries guidelines within the required timelines as applicable.


* • Create and/or forward additional information, follow up questions as part of complaint investigation.

Assign the appropriate complaint system activities to other sites to ensure timely execution of complaint investigation and complaint file management


* • Appropriately utilize risk management documentation to support the complaint's regulatory reporting process o Involved in the maintenance of the Reportable Malfunction List and regulatory reporting tables in support of complaint management database activities as applicable.


* • Manage Standard and non-Standard Health Authority Requests of Health Authorities incl...